CHMP backs two antibiotics and Merck & Co HIV combo

The latest set of opinions from advisors to the European Medicines Agency include recommendations for three therapies from The Medicines Company, a HIV combination from Merck & Co and label extensions for key offerings from Novartis and Celgene.

First up, the agency's Committee for Medicinal Products for Human Use has backed granting marketing authorisation for the antibiotic Sivextro (tedizolid) from Merck & Co’s recently-acquired Cubist Pharmaceuticals. The drug has been recommended for the treatment of acute bacterial skin and skin structure infections.

The CHMP also backed The Medicines Company’s Orbactiv (oritavancin), for the same indication as Cubist’s drug, and two of the firm's other therapies - Kengrexal (cangrelor) an antiplatelet agent for the reduction of thrombotic cardiovascular events and Raplixa (human fibrinogen/human thrombin) as a supportive treatment where standard surgical techniques are insufficient for the improvement of haemostasis.

The committee also gave the thumbs-up to Merck & Co's Dutrebis (lamivudine/raltegravir) for HIV and Santen's Ikervis (ciclosporin) for the treatment of severe keratitis in adults with dry eye disease which has not improved despite tear substitutes. There was also a recommendation for Novo Nordisk’s Saxenda (liraglutide 3mg; see link).